Analysis of the Efficacy and Stability of a Wearable ECG Monitor

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorMezoo Co., Ltd.

About this trial

This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 19 years or older

Patients admitted to Chonnam National University Hospital who require ECG monitoring

Individuals who have expressed their intention to participate in this study or have obtained written consent from a proxy

Disqualifiers

Individuals who are unable to provide consent themselves or through a legally designated representative

Individuals deemed unsuitable for participation in the clinical trial based on the researcher's judgment

Trial design

Design model

Single group

Treatments tested in this trial

  • ECG monitoring by telemetry device and patch-type ECG monitor at the same time

    Device

    The patient undergoes electrocardiogram monitoring simultaneously through a telemetry device and a patch-type electrocardiograph.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ECG monitoring by telemetry device and patch-type ECG monitor at the same timeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The number of total QRS complex

Number of total QRS complex is compared based on the data obtained simultaneously from two devices.

Time frame
Within 3 months after electrocardiogram monitoring procedure
2

The rate of signal loss

Rate of signal loss is compared based on the data obtained simultaneously from two devices.

Time frame
Within 3 months after electrocardiogram monitoring procedure

Secondary outcomes

1

Average heart rate

Average heart rate is compared based on the data obtained simultaneously from two devices.

Time frame
Within 3 months after electrocardiogram monitoring procedure
2

The number of arrhythmia and technical alarm

Number of arrhythmia and technical alarm is compared based on the data obtained simultaneously from two devices.

Time frame
Within 3 months after electrocardiogram monitoring procedure
3

Results of satisfaction survey

Satisfaction survey responses from the medical staff

Time frame
Within 3 months after electrocardiogram monitoring procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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